RT Journal Article SR Electronic T1 Safety of long-acting β-agonist (LABA) withdrawal in patients in two clinical asthma trials JF European Respiratory Journal JO Eur Respir J FD European Respiratory Society SP 161 VO 40 IS Suppl 56 A1 Ronald A. Simon A1 David S. Pearlman A1 Yun Chon A1 Joseph H. Lin A1 Shao-Lee Lin YR 2012 UL http://erj.ersjournals.com/content/40/Suppl_56/161.abstract AB Background: LABAs are used with inhaled corticosteroids (ICS) for asthma treatment. Due to safety concerns, the US FDA has recommended stopping LABA therapy when asthma control is achieved. Little data exists on the effect of LABA withdrawal in patients on LABA/ICS therapy.Objective: To evaluate safety of LABA withdrawal up to 6 months in clinical trial patients on LABA/ICS therapy.Methods: Patients receiving LABA/ICS therapy at enrollment in Amgen AMG 317 and AMG 853 clinical trials underwent LABA withdrawal at screening. Patients who received either inefficacious treatment with study drug or placebo were analyzed. Clinical endpoints were change from screening in prebronchodilator forced expiratory volume in 1 second (FEV1), percentage of predicted prebronchodilator FEV1, Asthma Control Questionnaire (ACQ) score, daily rescue medication use, daily symptom eDiary, exacerbation incidence, and adverse events.Results: A total of 366 patients were previously treated with ICS+LABA (underwent withdrawal), and 177 patients were treated with ICS only. Changes in prebronchodilator FEV1, percentage of predicted prebronchodilator FEV1, ACQ score, daily rescue medication use, symptoms, and exacerbation incidence were not significantly different between patients with previous LABA use and those without. Time to exacerbation did not differ between groups (log rank test P=0.4112; Cox regression analysis P=0.9755, adjusted for screening characteristics). Adverse events were similar between groups. Similar patterns were observed in placebo patients.Conclusions: Asthma symptoms, lung function, and exacerbations were not significantly affected by LABA withdrawal in these clinical trial patients.